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Article History

Received: 6 December 2024

Accepted: 26 September 2025

First Online: 21 October 2025

Declarations

:

: The study protocol was approved by responsible ethics committees at the regional medical chambers of Hesse (Landesaerztekammer Hessen, Frankfurt/Main), Hamburg (Aerztekammer Hamburg), and North-Rhine (Aerztekammer Nordrhein, Duesseldorf) in Germany, and Instituto Clinica Humanitas, Milano, Italy. All patients provided written informed consent prior to any study-related activities. The research was conducted in accordance with the principles of the Declaration of Helsinki.

: Not applicable.

: KMB (personal and/or institution, past five years) has received compensations for services on advisory boards or consulting for AstraZeneca, Berlin Chemie, Boehringer, Bosch Healthcare Solutions, Clario, Chiesi, GSK, ICON, Novartis, Pohl Boskamp, Teva, Sanofi; received compensations for speaker activities in scientific meetings supported by AstraZeneca, Berlin Chemie, Bosch Healthcare Solutions, Chiesi, Clario, GSK, Novartis, Orion, Pohl Boskamp, Sanofi; received compensation for design and performance of clinical trials from AstraZeneca, Bosch Healthcare Solutions, GSK, Novartis, Pearl Therapeutics, Teva, Sterna.EH reports personal fees for: consulting activities from Sanofi, Regeneron, GSK, Novartis, AstraZeneca, Stallergenes-Greer, Chiesi, Almirall, Bosch, Lofarma; lecturing and educational activities from Sanofi, Regeneron, GSK, Novartis, AstraZeneca, Stallergenes-Greer, Chiesi, Almirall, Bosch, Lofarma; participation on data safety monitoring or advisoray boards from Sanofi, Regeneron, GSK, Novartis, AstraZeneca, Stallergenes-Greer, Chiesi, Almirall, Bosch, Lofarma. HT reports fees for speaker, lecturing and consulting activities, and/or research grants from AstraZeneca, Almirall, Astellas Pharma, Bayer, Boehringer Ingelheim, Berlin-Chemie, Chiesi, GSK, Leti Pharma, Meda, Mundipharma, Novartis, Nycomed, Pfizer, Sanofi, Takeda, Teva. SW is an employee of ACOMED Statistik. The institution received compensation for performing statistical analyses from Bosch Healthcare Solutions GmbH. AS was an employee of Bosch Healthcare Solutions GmbH at the time the study was conducted. SW is a full-time employee of Bosch Healthcare Solutions GmbH. Bosch Healthcare Solutions GmbH, the manufacture of the Vivatmo me device and app was the sponsor of the trial.

: KMB, EH, HT, SW, AS and SW declare no non-financial competing interests exist.